Pharmaceutical Technology

SEPTEMBER 10, 2008

NC: What are the most recent developments in your genotoxicity studies and which are proving most successful? IS: Our genotoxicity testing includes the core battery of the tests requested by EMEA/ICH including mutagenicity in vitro, chromosomal aberration test in vitro and micronucleus test in vivo.

In-Vitro 100

In-Vitro Genotoxicity In-Vivo Development 100

Camargo

APRIL 20, 2021

Sponsors can select the patient population and leverage companion diagnostics, and nonclinical study requirements such as genotoxicity and carcinogenicity studies can often be waived or delayed to later stages of development, especially for end-stage cancer therapies.

Development 137

Development Genotoxicity Production Drugs 137

Pharmaceutical Technology

DECEMBER 9, 2022

Dedicated experts in extractables and leachables and genotoxic impurities (GTIs) deploy organic trace analysis by liquid chromatography-mass spectrometry (LC-MS), as well as gas chromatography-mass spectrometry (GC-MS) equipment. All our equipment is in line with the latest European Medicines Agency (EMA) and FDA methods.

Development 130

Development Production Manufacturing Vaccination 130

Pharmaceutical Technology

JUNE 26, 2022

Quotient Sciences’ capabilities in drug substance services include: PR&D Analytical method development and validation Salt selection and polymorph screening Non-GMP, GMP, and commercial drug substance manufacturing Pre-formulation development DoE Thermal hazard and reactivity assessment Stability testing Proven acceptable range (PAR) and critical (..)

Manufacturing 130

Manufacturing Drugs Production Development 130

XTalks

MAY 13, 2022

FDA prefers the use of DEREK, a knowledge-based expert system for the qualitative prediction of toxicity, and SARAH, a statistical software to identify potentially toxic chemicals for assessment of genotoxic and sensitization potential. Tox Tree and grouping by Cramer rules are starting to lose favor with the FDA. Analytical Instrumentation.

Packaging 98

Packaging Packaging Containment Production 98

The Pharma Data

MARCH 25, 2021

IBRANCE may impair fertility in males and has the potential to cause genotoxicity. Advise females of reproductive potential to use effective contraception during IBRANCE treatment and for at least 3 weeks after the last dose. Advise male patients to consider sperm preservation before taking IBRANCE.

HR 52

HR Clinical Trials Clinical Trials Trials 52

The Pharma Data

FEBRUARY 8, 2021

IBRANCE may impair fertility in males and has the potential to cause genotoxicity. Advise females of reproductive potential to use effective contraception during IBRANCE treatment and for at least 3 weeks after the last dose. Advise male patients to consider sperm preservation before taking IBRANCE.

HR 52

HR Clinical Trials Clinical Trials Containment 52

FDA Law Blog

OCTOBER 10, 2023

subacute/subchronic toxicity, genotoxicity, implantation, hemocompatibility, chronic toxicity, carcinogenicity, reproductive/developmental toxicity and degradation).

In-Vivo 45

In-Vivo Manufacturing Engineer Genotoxicity 45

The Pharma Data

MARCH 8, 2021

The totality of the data from these studies indicates that molnupiravir is not mutagenic or genotoxic in in vivo mammalian systems. “We Animals were administered molnupiravir for longer and at higher doses (mg/Kg) than those employed in human studies.

Trials 69

Trials In-Vivo Genotoxicity RNA 69

The Pharma Data

MARCH 25, 2021

SG contains a genotoxic component and can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. Embryo-Fetal Toxicity. Advise pregnant women and females of reproductive potential of the potential risk to a fetus.

Genotoxicity 52

Genotoxicity Genotype Containment Protein 52

The Pharma Data

APRIL 14, 2021

TRODELVY contains a genotoxic component, SN-38, and targets rapidly dividing cells. Embryo-Fetal Toxicity: Based on its mechanism of action, TRODELVY can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus.

Genotype 52

Genotype Containment FDA Approval Genotoxicity 52

The Pharma Data

APRIL 7, 2021

TRODELVY contains a genotoxic component, SN-38, and targets rapidly dividing cells. Embryo-Fetal Toxicity: Based on its mechanism of action, TRODELVY can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus.

HR 52

HR Genotype FDA Approval Genotoxicity 52

The Pharma Data

MAY 13, 2021

Exposure to sorbitol during lactation causes metabolic alterations and genotoxic effects in rat offspring. Proceedings of the National Academy of Sciences of the United States of America. 2012;109(16):5984-5988. DOI: 10.1073/pnas.1120794109. 1120794109. Cardoso FS, Araujo-Lima CF, Aiub CA, Felzenszwalb I. Toxicol Lett. 2016;260:36-45.

Insulin 52

Insulin Production Hormones Medicine 52

FDA Law Blog

NOVEMBER 20, 2024

For FDA submissions, this strategy can be used to evaluate the biocompatibility endpoints acute, subacute, subchronic, and chronic systemic toxicity, genotoxicity, carcinogenicity, and reproductive/developmental toxicity. Data from chemical characterization studies must be evaluated in a separate TRA following ISO 10993-17 guidelines.

Manufacturing 59

Manufacturing Genotoxicity Containment Regulation 59